Posted by Michael Wonder on 21 Jul 2022
Sandoz supplemental biologics license application accepted by US FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 July 2022 - Submission supported by comprehensive analytical data package and clinical Phase I pharmacokinetics bridging study.
Sandoz today announced that the US FDA has accepted for review its supplemental biologics license application for a high concentration formulation of 100 mg/mL of its biosimilar Hyrimoz (adalimumab-adaz).
The application includes the indications of the reference medicine Humira (adalimumab) not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
